Device Classification Name |
tube tracheostomy and tube cuff
|
510(k) Number |
K182861 |
Device Name |
Shiley Neonatal/Pediatric Tracheostomy Tube |
Applicant |
Covidien |
6135 Gunbarrel Ave |
Boulder,
CO
80301
|
|
Applicant Contact |
Yaara Basevitch |
Correspondent |
Covidien |
6135 Gunbarrel Ave |
Boulder,
CO
80301
|
|
Correspondent Contact |
Yaara Basevitch |
Regulation Number | 868.5800
|
Classification Product Code |
|
Date Received | 10/11/2018 |
Decision Date | 03/22/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|